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ACR20 response was significantly higher in patients receiving either deucravacitinib 6 mg daily or 12 mg daily when compared with placebo.
Deucravacitinib, a novel oral selective tyrosine kinase 2 (TYK2) inhibitor, was well tolerated and had greater improvements in American College of Rheumatology-20 (ACR20) in patients with psoriatic arthritis when compared with controls, according to a study published in BMJ.1
“The options for targeted oral therapies in psoriatic arthritis are limited,” investigators stated. “Deucravacitinib may be a promising option for treatment of patients with active psoriatic arthritis.”
Initiated in March 2019, this double-blind, phase 2 trial, patients with PsA around the world (United States of America, Poland, Russia, Czech Republic, Germany, Hungary, and Spain) were randomized 1:1:1 to receive oral placebo (n = 66), deucravacitinib 6 mg once daily (n = 70), or 12 mg once daily (n = 67). Eligible patients had a PsA diagnosis for at least 6 months, had active joint disease, failed to respond to or were intolerant to ≥1 previous therapy, met the Classification Criteria for Psoriatic Arthritis (CASPAR), and had a high-sensitivity C-reactive protein (hs-CRP) level of ≥3 mg/L.
The primary endpoint was ACR20 response rate at week 16.
Of the 203 patients included in the study, demographics and disease characteristics at baseline were similar across all treatment groups. The mean age was 49.6 years, roughly half (51.2%) were female, and nearly all (98%) were White. The median PsA duration of disease activity was 4.5 years.
ACR20 response was significantly higher in patients receiving either deucravacitinib 6 mg daily (52.9%, p=0.0134) or 12 mg daily (62.7%, p=0.0004) when compared with placebo (31.8%) at week 16.
In the multiplicity-controlled secondary endpoints of change from baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) and Short Form-36 Physical Component Summary score and in Psoriasis Area and Severity Index-75 response, both doses of deucravacitinib showed significant improvements (p≤0.05).
ACR20 response rate was higher regardless of prior tumor necrosis factor inhibitor (TNFi) exposure, body weight, or gender.
The most common adverse events (AEs) (≥5%) in patients receiving deucravacitinib were nasopharyngitis, sinusitis, bronchitis, upper respiratory tract infection, rash, headache, and diarrhea.
No serious AEs, including major cardiovascular events, were reported. A total of 65.7% in both deucravacitinib groups and 42.% in the placebo group reported any AEs. There were no differences across treatment groups.
The study was limited by the relatively small sample size and that results were focused on only 16 weeks of treatment, which hinders generalizability.
“Deucravacitinib showed efficacy across multiple disease domains and patient-reported outcomes and has a safety profile that is consistent with its mechanism of action and with that observed in previous phase 2 and phase 3 trials in psoriasis (PsO),” investigators concluded. “Larger trials over longer durations are warranted to establish the long-term efficacy and safety profile of deucravacitinib in patients with active PsA.”
Mease PJ, Deodhar AA, van der Heijde D, et al. Efficacy and safety of selective TYK2 inhibitor, deucravacitinib, in a phase II trial in psoriatic arthritis [published online ahead of print, 2022 Mar 3]. Ann Rheum Dis. 2022;annrheumdis-2021-221664. doi:10.1136/annrheumdis-2021-221664